Package leaflet: Information for the patient

Aleric Deslo Active, 5 mg, coated tablets
Desloratadine
Please read this leaflet carefully before using the medicine, as it contains important information for the patient.
This medicine should always be used exactly as described in this patient leaflet or as directed by a doctor or pharmacist.

Keep this leaflet, so that you can read it again if necessary.
If you need advice or further information, please consult your doctor or pharmacist.
If you experience any adverse reactions, including any possible side effects not listed in this leaflet, inform your doctor or pharmacist. See section 4.
If there is no improvement after 3 days or if your condition worsens, contact your doctor.

Contents of the leaflet:

What Aleric Deslo Active is and what it is used for
Important information before taking Aleric Deslo Active
How to take Aleric Deslo Active
Possible side effects
How to store Aleric Deslo Active
Contents of the pack and other information

1. What Aleric Deslo Active is and what it is used for

What Aleric Deslo Active is
Aleric Deslo Active contains desloratadine, which is an antihistamine medicine.
How Aleric Deslo Active works
Aleric Deslo Active is an antiallergy medicine that does not cause drowsiness. It helps control allergic reactions and their symptoms.
When Aleric Deslo Active should be used
Aleric Deslo Active relieves symptoms associated with allergic rhinitis (inflammation of the nasal mucosa caused by allergy, for example hay fever or dust mite allergy) in adults and adolescents aged 12 years and older. Symptoms of this condition include: sneezing, nasal itching or discharge, itching of the palate, and itchy, red or watery eyes.
Aleric Deslo Active is also used to relieve symptoms associated with urticaria (a skin condition caused by allergy). Symptoms of this condition include: skin itching and hives.
Relief from these symptoms lasts throughout the day, helping patients return to normal daily activities and achieve normal sleep.
If there is no improvement after 3 days or if your condition worsens, consult your doctor.

2. Important information before taking Aleric Deslo Active

When not to take Aleric Deslo Active

if the patient is allergic to desloratadine or any of the other ingredients of this medicine (listed in section 6), or to loratadine.

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Warnings and precautions
Before starting treatment with Aleric Deslo Active, consult your doctor or
pharmacist:

if the patient has kidney function disorders;
if the patient has a history or family history of seizures.

Children and adolescents
This medicine should not be used in children under 12 years of age.
Aleric Deslo Active and other medicines
No interactions between Aleric Deslo Active and other medicines are known.
You should inform your doctor or pharmacist about all medicines currently used or recently used, as well as any medicines the patient intends to use.
Taking Aleric Deslo Active with food, drink and alcohol
Aleric Deslo Active may be taken with or without food.
Caution should be exercised when taking this medicine with alcohol.
Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult a doctor or pharmacist before using this medicine.
The use of Aleric Deslo Active during pregnancy or breastfeeding is not recommended.
Fertility
There are no available data on the effect on fertility in men and women.
Driving and operating machinery
It is not expected that this medicine, when used at the recommended dose, affects the ability to drive or operate machinery. Although drowsiness does not occur in most people, it is recommended to refrain from activities requiring concentration, such as driving or operating machinery, until the individual's response to this medicine is known.
3. How to take Aleric Deslo Active
This medicine should always be taken exactly as described in the patient leaflet or as directed by the doctor or pharmacist. In case of doubt, consult your doctor or pharmacist.
Adults and adolescents (aged 12 years and older)
The recommended dose is one tablet once daily, taken with water, with or without food.
This medicine is for oral use.
The tablet should be swallowed whole.
Do not use this medicine for longer than 10 days without consulting a doctor.
If there is no improvement after 3 days, or if the patient feels worse, consult a doctor.
Taking more Aleric Deslo Active than recommended
Aleric Deslo Active should be taken according to the instructions provided in the leaflet.
After accidental overdose, severe adverse effects are not expected. However,
in case of ingestion of a higher than recommended dose of Aleric Deslo Active, contact your doctor or pharmacist immediately.
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If you miss a dose of Aleric Deslo Active
If a dose is missed, take it as soon as possible, then continue with the regular dosing schedule. Do not take a double dose to make up for a missed dose.
Stopping Aleric Deslo Active
If you have any further questions about the use of this medicine, consult your doctor, pharmacist or nurse.

4. Possible adverse reactions

Like any medicine, this medicine can cause adverse reactions, although not everyone experiences them.
Very rarely, severe allergic reactions (difficulty breathing, wheezing, itching, hives and swelling) and skin rash have been reported since desloratadine has been marketed. If any of these severe adverse reactions occur, discontinue use of the medicine immediately and consult a doctor without delay.

In adult patients, adverse reactions were almost the same as with placebo tablets (tablets without active substance). However, fatigue, dry mouth and headache were reported more frequently than with placebo tablets.

In adolescents, headache was the most commonly reported adverse reaction.

The following adverse reactions have been reported in clinical trials with desloratadine:

Common: may affect up to 1 in 10 patients

fatigue ● headache ● dry mouth

The following adverse reactions have been reported since desloratadine has been marketed:

Very rare: may affect up to 1 in 10,000 patients:

severe allergic reactions ● rash ● palpitations and irregular heartbeat
rapid heartbeat ● abdominal pain ● nausea
vomiting ● stomach discomfort ● diarrhoea
dizziness ● somnolence ● insomnia
muscle pain ● hallucinations ● seizures
restlessness with excessive motor activity ● hepatitis ● abnormal liver function tests

Frequency not known: frequency cannot be estimated from the available data

unusual weakness ● yellowing of the skin and/or eyes
increased sensitivity of the skin to sunlight, even on cloudy days, and to UV (ultraviolet) radiation, for example UV radiation in sunbeds
change in heartbeat rhythm
unusual behaviour
aggressive behaviour
weight gain
increased appetite
- low mood
- dry eyes

Children
Frequency not known: frequency cannot be estimated from the available data

slow heartbeat
change in heartbeat rhythm
unusual behaviour
aggressive behaviour
weight gain
increased appetite

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel: +48 22 49 21 301, Fax: +48 22 49 21 309, Website: https://smz.ezdrowie.gov.pl. Adverse reactions may also be reported to the marketing authorization holder. Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Aleric Deslo Active

Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and blister after EXP. The expiry date refers to the last day of the stated month.
Store in the original packaging to protect from light.
Do not use this medicine if you notice any change in the appearance of the tablets.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Aleric Deslo Active contains

The active substance is desloratadine 5 mg.
Other components of the medicine are: tablet core: microcrystalline cellulose, pregelatinized starch, corn starch, magnesium stearate, and colloidal anhydrous silica.
Film-coating: Opadry blue 03A30735 (containing: hypromellose 6 cP, titanium dioxide (E 171), microcrystalline cellulose, stearic acid, and indigo carmine (E 132)).

What Aleric Deslo Active looks like and contents of the pack
Aleric Deslo Active 5 mg coated tablets are blue, round, and biconvex.
Aleric Deslo Active coated tablets are packed in containers containing 1, 2, 3, 5, 7, or 10 coated tablets.
Marketing Authorisation Holder:
US Pharmacia Sp. z o.o.
Ziębicka 40 Street
50-507 Wrocław
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Manufacturer:
Genepharm S.A.,
18 km Marathon Avenue,
15351 Pallini,
Greece
For further information, please contact:
USP Zdrowie Sp. z o.o.
Poleczki 35 Street
02-822 Warsaw
Phone: +48 (22) 543 60 00
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